FDA Adverse Event
Malfunction
Summary report: N
EZ-IO POWER DRIVER
MDR report key: 1335404
·
Received March 4, 2009
Report
- Report Number
- MW5010193
- Event Type
- Malfunction
- Date Received
- March 4, 2009
- Date of Event
- March 3, 2009
- Report Date
- March 4, 2009
- Manufacturer
- VIDACARE CORPORATION
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
ON SCENE OF PT WITH MULTIPLE GUN SHOT WOUNDS. UNABLE TO SEE VIABLE I.V. SITES IMMEDIATELY SO INITIATED USE OF THE INTRAOSSEOUS DRILL. WHEN INSERTING NEEDLE INTO THE RIGHT TIBULA THE I.O. DRILL BOGGED DOWN, BATTERY DIED AND UNABLE TO INSERT. FORTUNATELY, WE WERE ABLE TO OBTAIN ONE I.V. ANTECUBITAL WITH AN 18G CATHETER. THE PT COULD HAVE USED AN ADDITIONAL LINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EZ-IO POWER DRIVER | EZ-IO POWER DRILL | HTW | VIDACARE CORPORATION | 011782 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other |